IMPORTANT SAFETY INFORMATION: WARNING: RISK OF ANAPHYLAXIS, HYPERSENSITIVITY AND IMMUNE-MEDIATED REACTIONS, AND RISK OF CARDIORESPIRATORY FAILURE If you or your child is taking Lumizyme, you should know that severe and potentially life-threatening allergic-type reactions known as anaphylaxis, severe hypersensitivity reactions, and reactions related to the immune system may occur during and after Lumizyme treatment. These reactions may include extreme difficulty breathing, shallow breathing, abnormal heart rate, low blood pressure, throat tightness, face and tongue swelling, kidney dysfunction, and severe skin lesions. You should seek immediate medical care if signs and symptoms of anaphylaxis, hypersensitivity reactions, and immune system reactions occur. View more

THE TREATMENT EXPERIENCE

Lumizyme® (alglucosidase alfa) treatment is administered to patients by intravenous (IV) infusion, a process that involves infusing the medicine into a vein so that it can get into your bloodstream. Like other protein-based medications, Lumizyme cannot be taken as an oral treatment because proteins are destroyed in the digestive system. Infusion into the bloodstream bypasses the body's digestive processes.

Treatment Overview

The recommended dosage of Lumizyme is 20 milligrams for each kilogram (about 2.22 pounds) of body weight—your doctor will calculate the appropriate dosage for you

Each infusion takes approximately 4 hours to administer a full dose of Lumizyme

The recommended infusion schedule is once every 2 weeks

Talk to your doctor for more details about what to expect during and after your infusions. The following information may help you prepare for the experience of receiving Lumizyme treatment.

Before Infusions

Before you start Lumizyme treatment, be sure to discuss any general health or medical issues with your doctor—even if you think they’re not related to your Pompe disease—as they may affect how your doctor will plan your treatment. You should also alert your doctor before each infusion if any of these change:

Any new respiratory difficulties, colds, or infections

You are or think you may be pregnant, plan to become pregnant, or are breast-feeding

Any medical problems or allergies, now or in the past

Preparation and Administration of Infusions

1. Lumizyme infusions are administered by a healthcare professional.

2. Lumizyme infusion solution is prepared by adding sterile water to each vial of dry powder then transferring that liquid to an infusion bag of normal saline. The total infusion volume depends on your Lumizyme dose, which your doctor will calculate based on your body weight.

3. The infusion needle will be inserted into a vein, usually in your arm or hand. If your veins are difficult to access, or you are anxious about needles, there are options that can help.

4. It will take several hours to receive the entire infusion. During this time you can participate in many types of activities, for example: reading, watching television, sleeping, visiting with family and friends.

5. During your infusion a healthcare professional will monitor your vital signs to see how your body is reacting to Lumizyme and for potential life-threatening reactions. If you experience severe allergic reactions, the infusion should be stopped and you will receive appropriate medical treatment. Be sure to communicate to your provider about any reactions you experience or observe during or after your infusions.

Indication

Important Safety Information

WARNING: RISK OF ANAPHYLAXIS, HYPERSENSITIVITY AND IMMUNE-MEDIATED REACTIONS, AND RISK OF CARDIORESPIRATORY FAILURE

If you or your child is taking Lumizyme, you should know that severe and potentially life-threatening allergic-type reactions known as anaphylaxis, severe hypersensitivity reactions, and reactions related to the immune system may occur during and after Lumizyme treatment. These reactions may include extreme difficulty breathing, shallow breathing, abnormal heart rate, low blood pressure, throat tightness, face and tongue swelling, kidney dysfunction, and severe skin lesions. You should seek immediate medical care if signs and symptoms of anaphylaxis, hypersensitivity reactions, and immune system reactions occur. If such a reaction is severe enough, your doctor may decide to immediately discontinue the infusion and provide immediate medical care. Appropriate medical support measures may be administered during your infusion, and you may require close observation during and after Lumizyme administration.

If your child has compromised breathing or heart function due to Pompe disease, there may be a risk of acute worsening of heart and/or lung function with Lumizyme due to the fluid from the infusion, and your doctor may decide that close observation during and after Lumizyme administration may be necessary.

Warnings and Precautions

Anaphylaxis and Hypersensitivity Reactions: Life-threatening anaphylaxis and hypersensitivity reactions have been observed in some patients during and after treatment with alglucosidase alfa. If such a reaction is severe enough, your doctor may decide to immediately discontinue the infusion and provide you with immediate medical care. Appropriate medical support and monitoring measures should be available during infusion.

Immune-Mediated Reactions: You or your child may be monitored for the development of systemic immune-mediated reactions while receiving Lumizyme. If these reactions occur, your doctor may discontinue the infusion and initiate appropriate medical treatment.

Risk of Acute Cardiorespiratory Failure: Infant Pompe patients with heart or breathing
problems who are experiencing an acute respiratory condition may be at risk for increasing the seriousness of these problems as a result of Lumizyme administration due to the infusion fluid, and your child’s doctor may require additional monitoring for these infants.

Risk of Cardiac Arrhythmia and Sudden Cardiac Death during General Anesthesia for Central Venous Catheter Placement: Caution should be used when administering general anesthesia for the placement of a central venous catheter intended for Lumizyme infusion. Ventricular arrhythmias and slow heart rate resulting in cardiac arrest or death have been observed in infant Pompe patients with cardiac hypertrophy during general anesthesia for central venous catheter placement. Appropriate medical support and monitoring measures should be available during infusion.

Risk of Antibody Development: Patients with infantile-onset Pompe disease (IOPD) should be managed by a clinical specialist knowledgeable in immune tolerance induction in Pompe disease to optimize treatment. Some patients who develop high and sustained IgG antibody levels, including certain IOPD patients, may have a reduced response to Lumizyme.

Monitoring: Laboratory Tests: Patients should be monitored for IgG antibody formation every 3 months for 2 years and then annually thereafter.

You are about to leave Lumizyme.com.

Sanofi Genzyme does not review or control the content of non-Sanofi Genzyme websites, and this hyperlink does not constitute an endorsement by Sanofi Genzyme of a non-Sanofi Genzyme site's content. Sanofi Genzyme’s privacy procedures do not apply to the owners of a non-Sanofi Genzyme website.